This invention relates to a method for reshaping a portion of an organism through implantation of an expandable prosthesis. This invention also relates to the prosthesis. The invention is particularly suitable for providing a female breast with a desired shape.
It is not uncommon for women afflicted with breast cancer to have a breast removed in an attempt to prevent spread of a malignancy. Mastectomies are not just physically traumatic but also psychologically scarring. At the very least, women who have suffered mastectomies may lose their self confidence.
A number of methods for breast implants have been developed, but more often than not, the resulting breast has an unnatural appearance. When an implant alone is used, a silicone sack filled with saline is disposed beneath the pectoral muscle. Although this bag is usually shaped in the form of a breast, the saline acts in accordance with the laws of fluids and distributes itself in the shape of least resistance so that the middle of the bag assumes a spherical shape. The lateral aspect of this prosthetic breast, where breast tissue is supposed to exist, is now empty. The resulting unnatural appearance is that of a ball placed beneath the skin rather than the tear-drop shape of a natural breast, with the sloping of the superior part of the breast, the even tapering distribution laterally and the droop on the inferior side.
It is an object of the present invention to provide a method and/or an associated prosthetic device for reconstructing and shaping a body part.
A more specific object of the present invention is to provide such a method and/or device for reconstructing and shaping a breast.
Another object of the present invention is to provide such a method and/or device which facilitates the fashioning of a natural breast shape.
It is a further object of the present invention to provide such a method and/or device which includes computer aided design.
These and other objects of the present invention will be apparent from the drawings and descriptions hereof. It is to be noted that every embodiment of the invention is expected to achieve one of more of these objects. However, no embodiment is expected to achieve all objects of the invention.
The present invention is directed in part to a method of breast reconstruction utilizing a breast prosthesis having a plurality of chambers or compartments distributed through a body member or shell in the form of a breast. The chambers are disposed along the superior, lateral and inferior surfaces, as well as in the interior, of the body member. The chambers are differentially pressurized in order to control the shape of the prosthesis upon implantation thereof. Chambers on the superior side of the body member are underpressurized or underfilled to result in a desired sloping aspect, whereas chambers on the inferior side are filled to a greater degree to provide a rounded full aspect. Chambers on the outer lateral side of the body member of the prosthesis are filled to intermediate levels to provide a gently rounded aspect, while chambers on the inner lateral side of the body member may be filled to a lower intermediate fill ratio to provide a more tapering aspect to that side of the reconfigured breast.
The present invention contemplates that the compartments or chambers of the prosthesis have shapes, sizes, and relative positions which facilitate the formation, after differential filling or pressurization of the chambers, of a reconstructed breast of a desired shape. The chamber configuration may vary among a number of different breast prostheses designed for generating breasts of different sizes and shapes.
Generally, a prosthesis in accordance with the present invention comprises a body member made of biocompatible material and having a plurality of inflatable chambers. Fluid guide elements are operatively connected to respective chambers for enabling a differential pressurization of the chambers with a fluid. The fluid is typically a saline solution but may take the form of any biocompatible fluid.
The guide elements may include a plurality of one-way valves each disposed between two adjacent chambers for enabling a transfer of fluid from one of the adjacent chambers to another upon an application of an external compressive force to the one adjacent chambers. Thus, the valves enable a reshaping of the breast merely through manipulation. Alternatively, non-invasive sculpting of the breast may be achieved by remote control where a signal receiver is embedded on or attached to the prosthesis, together with actuators for automatically opening and closing the valves in accordance with instructions received via the signal receiver. The signal receiver may be a wireless receiver which picks up radio-frequency electromagnetic signals or ultrasonic pressure wave signals.
The fluid guide elements may alternatively include a plurality of conduits connected to and communicating with respective ones of the chambers. The conduits may be provided with one-way valves for regulating the flow of fluid through the conduits. In that case, each chamber may be provided with a pair of conduits for alternatively delivering and removing fluid from the chamber.
In accordance with another feature of the present invention, the conduits may be connected also to at least one terminal connector or holder mounted to the body member. The terminal connector may be provided with indicators for identifying which chambers are connected to which conduit terminals. The indicators may consist of color coding or other marking scheme. Thus, by a simple visual inspection, a physician or other medical practitioner can easily locate a terminal for delivery of fluid to (or removal of fluid from) a desired chamber of the prosthesis.
In a particular configuration of the body member of the prosthesis, the valves are located at the ends of the conduits, in or proximate to the terminal connector on the body member of the prosthesis. The valves may then be operated manually.
In another mode of filling the chambers, an actuator mechanism is releasably coupled to the conduits and valves via the connector. In that case, the valves may be automatically operated by the actuator mechanism under the control of a computer to introduce fluid into the different chambers of the prosthesis in predetermined amounts. The amounts of fluid may be established by selecting one of a plurality of predetermined breast shapes, the fluid amounts being previously stored in a memory of the computer. Alternatively, the amounts of fluid may be calculated by the computer upon selecting of a breast shape.
A breast shape may be selected by several methods. For instance, where shapes are stored as electronic templates in a library of the computer""s memory, selection occurs upon viewing the different stored shapes on a computer monitor. For providing a better idea of the possible overall results, the various shapes from the library may be paired with an image (e.g., body-type silhouette or digitized photograph) of the woman undergoing breast reconstruction. Alternatively, a scanner may be used to digitally record the shape of her actual breast prior to removal thereof during surgery. The computer may then analyze the digitized shape and select a suitable prosthesis configuration and a set of fluid levels for the various chambers of the selected prosthesis, to most closely reproduce the recorded breast shape and size. The computer may be programmed to select or fine-tune the fluid levels in the different chambers of a selected prosthesis in order to most closely approximate the size and shape of the breast prior to surgery. Where a breast has already been removed by surgery, the other breast of the woman may serve as a template for selecting a prosthesis and pressure or fluid levels.
In accordance with another feature of the present invention, the guide elements of the prosthesis include a plurality of radio-opaque markers (e.g., rings) disposed on the body member adjacent to respective chambers for facilitating a selection of needle insertion points for the respective chambers. The markers thus serve to guide the hand of the physician, for instance, plastic surgeon or cosmetologist, during a fluid injection phase of a breast reconstruction procedure. It is well known that breast reconstruction requires several temporally spaced steps of incrementally increasing the amount of fluid in an implanted prosthesis, thus enabling a gradual stretching of the pectoral muscle. For this reason, the guide elements are helpful for facilitating repeated introduction of fluid to periodically elevate the fill levels in the compartments or chambers.
A method for reshaping a portion of an organism utilizes, in accordance with the present invention, a body member made of biocompatible material, the body member having a plurality of inflatable chambers. The method comprises implanting the body member into a patient in a pre-established location, selecting a desired shape of the portion of the organism, and differentially expanding the chambers with a fluid to respective fill levels to at least approximate the desired shape.
As discussed above, the selecting of the desired shape may include scanning a part of the organism to generate a digitized representation of the desired shape and loading the digitized representation into an electronic memory. The fill levels for the respective chamber are selected to generate the desired shape, this selection process including automatically analyzing the digitized representation to compute the fill levels.
Scanning of the body part may be achieved by any suitable technique, particularly by devices which generate digital representations of two- or three-dimensional forms. Useful scanning technologies include flying spot scanning, optical imaging by digital cameras, ultrasonic scanning, laser scanning, and mechanical sensing. In addition, cameras sensitive to electromagnetic wavelengths other than optical may be useful, for instance, those operating on infrared frequencies. Laser scanning takes surface slices of an object, based on distance from the laser. These slices are then reconstructed into a three-dimensional surface. This technique has been used in the film industry to scan an actor""s body into an electronic database for purposes of generating a three-dimensional animated image.
Where a human breast is to be reconstructed, for instance, following a mastectomy, the scanned body part is either the breast to be removed or, alternatively, the other breast of the patient. In the former case, the breast with the cancer or other degenerative disease has not substantially lost its original healthy shape at the time the decision is made to resect the breast. In the latter case, the mastectomy may have already occurred or the breast may have otherwise been altered from its natural form. The electronic three-dimensional image of the healthy breast is processed to undergo a mirror-image conversion to produce an electronic facsimile of the removed or diseased breast.
It is to be noted that all of the above-mentioned scanning techniques may be used either directly on the body part being scanned or indirectly, for instance, on a casting of the body part. More specifically, a mold may be made of the body part. The mold may be fabricated by placing plaster-soaked fabric on the body part, with the plaster being permitted to harden to form a mold. In any event, the electronic surface or contour data may be generated by scanning the inner surface of the mold or by scanning an exterior surface of a casting made via the mold.
As further discussed above, the selecting of the desired shape alternatively includes storing a library of possible shapes of the portion of the organism in an electronic memory, selecting a plurality of the possible shapes, generating on an image reproduction device a plurality of images each corresponding to a respective one of the selected possible shapes, and thereafter selecting one of the plurality of the possible shapes as the desired shape. In addition, a plurality of target fill levels for respective chambers of a prosthesis may be stored in the memory, for each of the possible shapes. Then, the selecting of the fill levels for the respective chambers includes automatically selecting the target fill levels corresponding to or associated with the desired shape in the memory.
Where the body member is provided with a plurality of conduits extending to respective chambers from a terminal connector on the body member, the differential expanding of the chambers may include coupling an inflation or fluid delivery connector to the terminal connector.
Where the body member is provided with a plurality of markers disposed adjacent to respective chambers, the expanding of the chambers includes scanning the patient to detect the markers, inserting a hollow needle into the chambers at respective locations indicated by the markers, and introducing a pressurization fluid into the chambers through the inserted needle.